FSD Pharma has initiated dosing of the first patient in its Phase IIa clinical trial of FSD201 (ultramicronized palmitoylethanolamide or ultramicronized PEA) for treating hospitalised patients with Covid-19.
The randomised, controlled, double-blind, multicentre FSD201 COVID-19 Trial will be carried out on 352 patients to evaluate the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily along with the standard of care (SOC) versus SOC alone in patients hospitalised with Covid-19.
Individuals with symptoms consistent with influenza / coronavirus signs such as fever, dry cough, malaise, difficulty in breathing and those with documented positive Covid-19 will be eligible to take part.
The company intends to conduct the trial in 25 to 30 medical centres and hospitals in North America.
The primary objective of the trial is to analyse whether FSD201 plus SOC can significantly improve patients’ clinical status such as shorter time to symptom relief.
The trial’s secondary objectives are analysing whether FSD201 plus SOC shows additional benefit in terms of safety, objective assessments such as time taken to normalisation of fever, time taken for improving oxygen saturation and time to clinical progression.
It also includes time to mechanical ventilation or hospitalisation, as well as the duration of hospital stay.
Cytokine clearance as measured by Enzyme Linked Immunosorbent Assay (ELISA) is the exploratory endpoint of the trial.
The patients will receive treatment for a period of 14 days and the primary endpoint will be determined at 28 days.
In August, FSD Pharma submitted an investigational new drug application (IND) to the US Food and Drug Administration (FDA) to assess FSD201 against Covid-19.
The company received approval to commence a Phase II trial of FSD201 in September.